Registration Dossier

Toxicological information

Repeated dose toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
sub-chronic toxicity: inhalation
Type of information:
other: evidence based on degradation product
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Referenceopen allclose all

Title:
European Union Risk Assessment Report - hydrogen fluoride
Year:
2001
Bibliographic source:
Luxembourg: Office for Official Publications of the European Communities, 2001
Reference Type:
study report
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: gas
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/m³ air (analytical)
Dose / conc.:
0.098 mg/m³ air (analytical)
Dose / conc.:
0.72 mg/m³ air (analytical)
Dose / conc.:
7.52 mg/m³ air (analytical)
No. of animals per sex per dose:
20
Details on study design:
In a 91 days subchronic study (Placke and Griffin 1991), also performed according to GLP with similarity to OECD 413 guideline, female and male rats (20/group) were exposed to 0, 0.082, 0.816 and 8.16 mg HF/m3 (nominal concentrations; actual concentrations were: 0, 0.098, 0.72
and 7.52 mg/m3, respectively) for 6 hours/d, 5 days/week.

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Mortality:
mortality observed, treatment-related
Body weight and weight changes:
effects observed, treatment-related

Effect levels

Key result
Dose descriptor:
NOAEL
Effect level:
0.72 mg/m³ air (analytical)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs
mortality
haematology
clinical biochemistry
organ weights and organ / body weight ratios

Applicant's summary and conclusion

Conclusions:
From EU Risk Assessment Report on hydrogen fluoride:
The available animal data set for HF permits the derivation of a NOAEL for repeated sub- chronic inhalatory exposure. No suitable studies are available for HF, for other routes of exposure. The over-all NOAEL for repeated inhalatory exposure is taken from the 91-day GLP study with female and male rats and amounts 0.72 mg HF/m3 (actual value) for a 6 h per d 5 d per week exposure regimen. At this exposure no adverse effects were observed. At the next exposure level death, tissue irritation, dental malformations, haematological and biological changes and changes in several organ weights were observed.